Pharmaceutical Stability Testing Program Audit Checklist

A comprehensive checklist for auditing pharmaceutical stability testing programs to ensure compliance with ICH guidelines, data integrity, and accurate shelf-life determination in drug development and manufacturing.

Pharmaceutical Stability Testing Program Audit Checklist
4.5

Get Template

About This Checklist

The Pharmaceutical Stability Testing Program Audit Checklist is an essential tool for ensuring the robustness and compliance of stability studies in pharmaceutical development and manufacturing. This comprehensive checklist addresses key aspects of stability testing, from study design to data analysis and reporting, helping to maintain product quality and shelf-life accuracy. By implementing this checklist, pharmaceutical companies can enhance their stability testing practices, meet regulatory requirements, and ensure the consistent quality and efficacy of their products throughout their intended storage period.

Learn more

Industry

Pharmaceuticals

Standard

ICH Q1A(R2) Stability Testing of New Drug Substances and Products

Workspaces

Clinical trial sites

Occupations

Stability Scientist
Quality Control Analyst
Regulatory Affairs Specialist
Formulation Scientist
Quality Assurance Manager

Get Early Access to Advanced Features

Join our early access program to fully cover your auditing processes with nonconformances, team access, multi-organization support, advanced analytics and more...

Generate AI-powered checklists tailored to your needs

Access a vast library of checklists for every industry

Create your own profile, connect with other professionals